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Michael Huerta, PhD
Associate Director for Program Development
National Library of Medicine, NIH
NIH Regional Seminar
June 2011
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SBIR & STTR Purpose
• Stimulate technological innovation
• Commercialize innovative technologies
• Stimulate small business & economic growth
• Foster technology transfer between small business concerns and research institutions
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Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of commercializable, innovative technologies
• Serving the mission & priority of the awarding unit (Institute or Center)
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Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of commercializable, innovative technologies
• Serving the mission of the awarding unit

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SBIR & STTR Awards
• Awards are funds to the small business from the federal government – control levels vary
• Grants
• Cooperative Agreements
• Contracts
• Awards support specific R & D projects (not general business costs, infrastructure, etc.)
• Awards do not require
• Repayment or debt service
• Equity or intellectual property forfeiture
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How much is awarded through
SBIR & STTR programs?
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How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
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How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
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How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
NIH SBIR: $616 M
NIH STTR: $ 74 M
Total: $690M
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How much is awarded through
SBIR & STTR programs?
$2.4 Billion in FY 2010
NIH SBIR: $616 M
NIH STTR: $ 74 M
Total: $690M
SBIR 2.5 %
STTR 0.3 %
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NIH SBIR & STTR Programs
Summary of Key Features
• SBIR & STTR Programs
 Single SBIR/STTR grant solicitation
 Investigator-initiated research ideas
 Special FOAs (see NIH Guide for
Grants and Contracts)
 Electronic Submission (grants only)
 Awards always made to small business concern
• External Peer Review
 Option to request review group
 Experts from Academia/Industry
 5 Criteria: Significance, Approach,
PI(s), Innovation, Environment
 Summary Statement for all applicants
 Revise & resubmit once
• Multiple Receipt Dates (Grants)
 April 5, August 5, December 5
 May 7, September 7, January 7 (AIDS)
 Contracts: Early November
• Gap Funding Programs
 Phase IIB Competing Renewals
 Ph I/Ph II Fast Track
 Administrative Supplements
• Budget and Project Period – Guidelines
 $100-150K/6 -12months (Ph I)
 $750K-1M/2 yrs (Ph II)
 Deviations permitted where scientifically appropriate (eg, FOAs)
• Technical Assistance Programs
 Technology Niche Assessment
 Commercialization Assistance
 Pipeline to Partnerships (P2P)
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SBIR and STTR:
Critical Differences
• Research Partner
 SBIR: Permits partnering
33% Phase I and 50% Phase II
• PI Employment
 SBIR: Primary employment
(>50%) must be with small business concern
 STTR: Requires partnering with
Research Institution
Small business (40%) and U.S. research institution (30%)
 STTR: PI may be employed by either research institution or small business concern
 Multiple PD/PI allowable – for
SBIR only one PI must be primarily employed by SBC
Award is always made to Small Business Concern
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Per Congressional Guidelines – FOAs Vary
PHASE I Feasibility Study
 Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs
 Project Period: 6 months (SBIR) or 1 year (STTR)
PHASE II Full Research/R&D
 $750K (STTR) or $1M (SBIR) over two years
PHASE IIB Competing Renewal/R&D
 Clinical R&D; Complex Instrumentation/Tools to FDA
 Many, but not all, ICs participate
 Varies ~$1M/year; 3 years
PHASE III Commercialization – not funded by gov’t
 NIH is generally not the “customer”
 Consider partnering and exit strategy early
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Phase IIB Competing Renewal Award
• Purpose: Peer-reviewed continuation of Phase II R & D for complex projects
• Parameters: Up to $1M/year for up to 3 years
• Eligibility: Must have Phase II award // contact program officer for eligibility
• Participating ICs: NIA, NIAAA, NIAID, NICHD, NIDA,
NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and
NCRR
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Beyond the Guidelines
The duration and amount of the SBIR or STTR award may exceed the congressional guidelines
• As required by the project – contact program officer before submitting the application to find out what would be allowed
• As allowed by special funding opportunity announcements
(FOAs), for example PA-11-134, Lab to Marketplace:
• Phase I – up to $350,000 per year for up to two years
• Phase II – up to $600,000 per year for up to three years
• Phase IIB – up to $800,000 per year for up to three years
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Beyond the Guidelines
The duration and amount of the SBIR or STTR award may exceed the congressional guidelines
One project could be supported with
~ $6 million over 8 years (Ph I, II, & IIB)!
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Phase I Phase II
• No-Cost Extension
• Phase I / Phase II Fast Track
• Administrative / Competitive
Supplements
Mind the Gap
Phase IIB Competing
Renewal Award
Mt. “FDA”
Phase III
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NIH Phase I/Phase II Fast-Track
Bridging the Phase I - II Funding Gap
SBIR/STTR Phase I + Phase II
7-9 months
(Simultaneous Submission and Concurrent Review)
Phase I Award
Completion of Phase I
Phase I Final Report Program Staff assess completion of specific aims and milestones
Go?
No Go?
Aims/Milestones
Met
Phase II award
Aims/Milestones
NOT Met
Phase II award
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Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of commercializable, innovative technologies
• Serving the mission of the awarding unit
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Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of commercializable, innovative technologies
• Serving the mission of the awarding unit
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SBIR/STTR Eligibility Criteria
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 U.S.
small business organized for-profit
 At least 51% U.S.- owned by individuals and independently operated or , for SBIR, at least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals
 500 or fewer employees, including affiliates
 SBIR: At least one PI primarily employed with the small business ( STTR: not stipulated)
 STTR: Formal collaboration between small business and research institution
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More SBIR/STTR Eligibility
Checkpoints
 STTR : Formal collaborative effort means:
• Minimum 40% by small business
• Minimum 30% by U.S. research institution
 STTR : Intellectual Property Agreement Needed
Allocation of Rights in IP and Rights to Carry out
Follow-on R&D and Commercialization
 SBIR/STTR : Applicant is Small Business Concern
 SBIR/STTR : All of the work must be done in the US
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Additional Eligibility Issues
• Eligibility is determined at time of award
• No appendices allowed in Phase I
• The PD/PI is not required to have a Ph.D.
• The PD/PI is required to have expertise to oversee project scientifically and technically
• Applications may be submitted to different agencies for similar work
• Awards may not be accepted from different agencies for duplicative projects
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Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of commercializable, innovative technologies
• Serving the mission of the awarding unit
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Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of commercializable, innovative technologies
• Serving the mission & priority of the awarding unit (Institute or Center)
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National Institute on Aging
NIH Institutes and Centers (ICs)
Office of the Director http://www.nih.gov/icd
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and
Infectious Diseases
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
National Cancer
Institute
National Institute of Child Health and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute of Dental and
Craniofacial
Research
National Institute of Diabetes and
Digestive and
Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental
Health Sciences
National Eye
Institute
National Institute of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute of Mental Health
National Institute of Neurological
Disorders and
Stroke
National Institute of Nursing Research
National Institute
On Minority Health and Health
Disparities
National Center for Complementary and Alternative
Medicine
Fogarty
International
Center
National Center for Research
Resources
National Library of Medicine
National Institute of Biomedical
Imaging and
Bioengineering
No funding authority
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NIH Institutes & Centers
SBIR & STTR Budget Allocations
FY 2010 SBIR/STTR
Budget Allocations to NIH ICs:
SBIR: $616 M
STTR:$ 74 M
Total: $690 M
NIGMS NIDDK
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Submitted grant applications get appropriate assignment
• Applications received by CSR and assigned to:
• A CSR (usually) study section for peer review
• An IC for programmatic (funding) consideration
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Submitted grant applications get appropriate assignment
• Applications received by CSR and assigned to:
• A CSR (usually) study section for peer review
• An IC for programmatic (funding) consideration
Appropriate, however, is not necessarily optimal
You can help determine optimal assignment
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Relationship between project and study section
• Dozens of study sections with different
• Areas of review responsibility
• Expertise of peer reviewers
• Overlap from one study section to another
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Relationship between project and study section
• Dozens of study sections with different
• Areas of review responsibility
• Expertise of peer reviewers
• Overlap from one study section to another
Each study section has unique scientific focus and each reviewer has unique perspective
Determine the best match for your project
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How to determine which study section is best for your project
• Center for Scientific Review (CSR) web site:
• Scientific focus of each study section
• List of study sections with similar scientific foci
• Roster of members of each study section
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How to determine which study section is best for your project
• Center for Scientific Review (CSR) web site:
• Scientific focus of each study section
• List of study sections with similar scientific foci
• Roster of members of each study section
If more than one seems great,
Communicate with scientific review officers of those study sections for further guidance
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Relationship between project and IC
• Dozens of ICs with different
• Missions – purviews of responsibility
• Priorities – areas of special interest or emphasis
• A project could match mission, but not priority!
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Relationship between project and IC
• Dozens of ICs with different
• Missions – purviews of responsibility
• Priorities – areas of special interest or emphasis
• A project could match mission, but not priority!
• Technologies are often cross-cutting, e.g.:
• Neuroimaging tool – cancer or stroke
• Microfluidic chamber – deliver drug or growth factor
• Context of grant application or test bed for proposed feasibility test may determine IC
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How to determine which IC is the best fit for your project
• Web sites of ICs
• List research priorities, strategic plans, etc.
• Annual Omnibus Solicitation for SBIR and
STTR Grant Applications
• ICs list specific research topics
• Special FOAs
• Clear indication of participating ICs’ interests
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How to determine which IC is the best fit for your project
• Web sites of ICs
• List research priorities, strategic plans, etc.
• Annual Omnibus Solicitation for SBIR and
STTR Grant Applications
• ICs list specific research topics
• Special FOAs
• Clear indication of participating ICs’ interests
After narrowing down list of possible ICs, talk to the program officer(s) about your specific idea
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Cover Letter - Follow up for optimal assignment
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• Request potential awarding component(s): NIH
Institutes/Centers – refer to program officer communication as appropriate
Request SBIR/STTR study section
Indicate key areas of review expertise required
Indicate individual(s)/organization(s) in conflict
For resubmission, indicate review history
Justify all the requests you make
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SBIR & STTR Purpose
• Stimulate technological innovation
• Commercialize innovative technologies
• Stimulate small business & economic growth
• Foster technology transfer between small business concerns and research institutions
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Achieving the Purpose
• Through SBIR & STTR awards
• To small businesses
• Supporting research & development of commercializable, innovative technologies
• Serving the mission & priority of the awarding unit (Institute or Center)
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Drilling Down
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Application & Review Process
Remember: First get registered in Grants.gov AND eRA Commons!
Small Business
Concern
Research idea – then contact NIH
Submits
SBIR/STTR Grant
Application to NIH
Electronically
NIH Center for Scientific Review
Assign to IC and Study Section
Scientific Review Groups
Evaluate Scientific Merit
~2-3 months after submission
IC Advisory Council or Board
Concurs with Review
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Grantee Conducts
Research
~2-3 months after review
IC
Allocates
Funds
IC Staff Prepare funding Plan for IC Director

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Review Criteria
• Overall Impact Score
• Scored Review Criteria (score 1-9)
 Significance (Real Problem/Commercial Potential)
 Investigators (PI and team)
 Innovation (New or Improved?)
 Approach (Research Design, Feasible)
 Environment (Facilities/Resources)
• Additional Review Criteria (not scored individually)
 Protection of Human Subjects
 Inclusion of Women, Minorities & Children
 Vertebrate Animals
 Biohazards
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NIH SBIR/STTR Success Rates FY2010
25
20
15
35
30
10
5
0
13,7
33,5
SBIR
15,6
34,8
FY2010 $690 M
SBIR/STTR
20,2
23,4
Phase I
Phase II
Fast-Track
STTR
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Keys to Success
• Understand mission & priorities
• IC Web sites, Omnibus Solicitation, FOAs
• Propose innovative ideas with significance as well as scientific and technical merit
• Give yourself ample time to prepare application
• Contact NIH Staff to discuss:
• Research idea early on – program staff
• Assignment issues – program and review staff
• Outcome of your review – program staff
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NIH Technical Assistance Program
Helping Companies cross the “Valley of Death”
Niche Assessment Program
Mt. “FDA”
???
Program
Phase I Phase II Phase III
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Technical Assistance Programs
Understanding the “B” in SBIR
Niche Assessment Identifies other uses of technology
(Phase I awardees)
Determines competitive advantages
Develops market entry strategy
Commercialization
Assistance
(Phase II awardees)
“Menu” of technical assistance/training programs in:
•Strategic/business planning
•FDA requirements
•Technology valuation
•Manufacturing issues
•Patent and licensing issues
Helps build strategic alliances
Facilitates investor partnerships
Individualized mentoring/consulting
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Finding a Partner
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NIH Pipeline to Partnerships
• Showcases SBIR/STTR (Phase I and Phase II) technologies and NIH-licensed technologies
• Facilitates matchmaking between NIH
SBIR/STTR awardees and potential strategic partners and investors
• Searches by application category (diagnostics, therapeutic, tool, etc.) and/or disease

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NIH Pipeline to Partnerships (P2P)
SBIR/STTR awardees and
NIH licensees can showcase technologies in a virtual space for potential partners.
http://www.ott.nih.gov/p2p/index.aspx
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NIH Pipeline to Partnerships (P2P)
POTENTIAL PARTNERS / INVESTORS
Identifies technology of interest and contacts company
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Summary of NIH SBIR & STTR
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• Investments in innovation & economic growth
• Advance the NIH mission & human health
• Support and validate small business R & D
• Extraordinary latitude in awards
• Extraordinary assistance from idea to market
• Scientific aspects
• Administrative aspects
• Business aspects
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Eligibility Criteria
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• Ownership: US-owned, independently operated
• Affiliations: Research Institutions,
Foundations, Foreign “Parents”
• Size: 500 employees maximum
• Business Structure: Inc, LLP, LLC, ...
• Principal Investigator: Employment
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Ownership And Affiliations
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• Owners of the SBIR organization must be
"individuals" who are "citizens of, or permanent resident aliens in, the United
States."
• The regulations nowhere provide that corporations or artificial entities may qualify as "individuals" who are U.S. citizens.
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Ownership And Affiliations
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FOREIGN
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more than 500
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Board of Directors
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PD/PI Eligibility on SBIR
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•
Eligibility is determined at the time of award
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STTR Eligibility Criteria
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•
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STTR Applicant Organization
ALWAYS
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STTR Research Institution
Partner
• Must establish formal collaborative relationship with SBC
• Must perform minimum of 30% of the research/R&D (maximum 60%)
• Non-profit organization owned and operated exclusively for scientific or educational purposes
• Non-profit medical and surgical hospitals
 eligible as partner as long as these institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques
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PD/PI Eligibility on STTR
• PD/PI: Not required to be employed by SBC
• PD/PI: Must commit 10% effort (minimum)
• PD/PI at RI: Must establish contract between
RI and SBC describing PD/PI’s involvement
PD/PI’s “signature” on Face Page represents agreement to conforming to Solicitation requirements
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PD/PI Role on STTR
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BUDGET PAGE
• PI must be on SBC or RI budget, but NOT BOTH
• PI and co-PI must be paid at either SBC or RI, but NOT BOTH
• PI oversees all research activities on behalf of
SBC
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PI Role on STTR
• NIH requires documentation from original employer/RI confirming change in employment status (e.g., sabbatical) for duration of
SBIR/STTR project
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• PI cannot serve as consultant on same project
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